ANDA 203003

LUPIN LTD

FDA Drug Application

Application #203003

Application Sponsors

ANDA 203003

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	12.5MG	0	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE
002	TABLET;ORAL	25MG	0	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE
003	TABLET;ORAL	50MG	0	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-11

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203003
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/11\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-11
        )

)